XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT

{0}------------------------------------------------ K030194 Page 1 of 3 # SMDA 510(k) SUMMARY MAR 2 4 2003 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR Section 807.92. # A. General Information | Applicant: | OLYMPUS OPTICAL CO.LTD. | |---------------------------------|------------------------------------------------------------------------| | Address: | 34-4 Hirai Hinode-machi, Nishitama-gun, Tokyo, Japan<br>190-0182 | | Establishment Registration No.: | 3003637092 | | Submission Correspondent: | Mayumi Ishii<br>OLYMPUS OPTICAL CO., LTD. | | Address: | 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, Japan | | Telephone: | 81-426-42-2891 | | Facsimile: | 81-426-42-2291 | | E-mail address: | ma_ishii@ot.olympus.co.jp | | Establishment Registration No.: | 8010047 | | Official Correspondent: | Laura Storms-Tyler | | Title: | Director, Regulatory Affairs/Quality Assurance<br>OLYMPUS AMERICA INC. | | Address: | Two Corporate Center Drive, Melville, NY 11747-3157 | | Telephone: | 631-844-5688 | | Facsimile: | 631-844-5416 | | E-mail address: | Laura.Storms-Tyler@olympus.com | | Establishment Registration No.: | 2429304 | # B. Device Identification | Device Name: | XUES-41 | |----------------------------|-----------------------------------------------------| | Common/Usual Name: | Electrosurgical Unit and its associated accessories | | Class: | II | | CFR Classification Number: | 21CFR 876.4300 | | Classification Panel: | Gastroenterology & Urology | | Product Code: | 78-KNS | | 514 Performance Standard: | Not established | # C. Predicate Devices: | Model | Device Description &<br>510(k)#/ Date Cleared | Manufacturer | |----------------------------------------|-----------------------------------------------|---------------------------| | OLYMPUS UES-30<br>ELECTROSURGICAL UNIT | #K023767<br>NOV/29/1997 | Olympus Optical Co., Ltd. | | GYRUS Endourology<br>System | #K990628<br>JUN/29/1999 | Gyrus Medical Ltd. | {1}------------------------------------------------ ### D. Description of the Device #### Standard Set The standard set of the XUES-41 Electrosurgical Unit includes the following components: | MODEL NAME | DEVICE DESCRIPTION | 510(K)# | |-------------|--------------------------------------|-------------------------| | XUES-41 | Electrosurgical Unit | Part of this submission | | Foot switch | Foot switch for Electrosurgical Unit | Part of this submission | | Power cord | Power cord | #K911904 | #### a) XUES-41 Electrosurgical Unit The Electrosurgical Unit XUES-41 produces the high frequency current waveform delivered to tissue via the electrosurgical accessories and electrodes. When the high frequency current is fed through tissue, it generates heat rises, causing changes from protein degeneration to desiccation and vaporization. #### b) Footswitch The Footswitch is designed to connect to the XUES-41 unit. It offers handsfree control of the ON/OFF function during the procedure. #### Recommended Accessories The following associated accessories are designed and recommended with the XUES-41 Electrosurgical Unit. | MODEL NAME | DEVICE DESCRIPTION | 510(K)# | |------------|--------------------------|-------------------------| | NA | A-Cord | K970184 | | MAJ-619 | A-Adapter | K970184 | | NA | Bipolar Electrodes | K970184 | | S1518/1 | Working Element, Passive | Part of this submission | | S1518/2 | Working Element, Active | Part of this submission | | S1518/3 | HF Resection Electrode | Part of this submission | | S1518/4 | HF-cable | Part of this submission | a) S1518-1/2/3/4 The S1518-1/2/3/4 are to be combined together and make up a high frequency therapeutic device. The S1518-1/2 are handle parts; the S1518-1's movement is passive and the \$1518-2's active. The S1518-3 consists of a cutting loop and stabilizing tube and it performs coagulation and cutting at the cutting loop by applying high frequency current. The S1518-4 is a HF cable to connect the XUES-41 and the combination of the S1518-1/2/3. The S1518-1/2/4 are reusable, while the S1518-3 is sterile, single use. #### E. Intended Use of the device This instrument has been designed for use in a medical facility under the supervision of a trained physician. It has been designed for general(open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes(fiberscopes, videoscopes and rigid scopes) {2}------------------------------------------------ Page 3 of 3 applicable for electrosurgery(cutting and coagulation), light sources and other ancillary equipment. ### F. Reason for Not Requiring Clinical Data The subject XUES-41 is similar to the OLYMPUS UES-30 Electrosurgical UNIT cleared in the previous 510(k) #K023767, Gyrus cleared in the previous 510(k) #990628. And when compared to the predicated devices listed above, the Olympus XUES-41 Electrosurgical UNIT does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore the clinical data is not necessary for its evaluation of safety and efficacy. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 4 2003 Olympus Optical Co., Ltd. c/o Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719 Re: K030194 Trade/Device Name: XUES-41 Endoscopic Electrosurgical Unit Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: March 17, 2003 Received: March 19, 2003 Dear Mr. Sherratt: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number(if known): . K030194 Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications for Use: This instrument has been designed for use in a medical facility under the supervision of a trained physician. It has been designed for general(open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes(fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery(cutting and coagulation), light sources and other ancillary equipment. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96) David A. Stamm (Division Sign-Off) Division of Reproductive and Radiological Devic 510(k) Number